(85 days)
DESS Multi-Unit Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes abutments cleared previously in K170588, K173908, K191986, K212577, K212628, K222269, and K22288. These previously cleared abutments are compatible with a variety of original equipment manufacturers (OEM) of dental implants. This submission adds abutments for implant lines from Implant Direct Sybron Manufacturing LLC (hereinafter, Implant Direct). The subject device abutments are compatible with various Implant Direct internal hex and internal conical implant bodies. The subject device abutments include Multi-Unit Abutments in straight, 17° angled, and 30° angled designs. All abutments are provided with the appropriate abutment screw (ff applicable) for attachment to the corresponding implant. All abutments and screws are provided non-sterile. The subject device is only intended for multi-unit restorations such as bridges and bars.
This appears to be a 510(k) Summary for a medical device (dental abutments) rather than a study report with acceptance criteria for an AI/ML powered device. The document describes the device, its intended use, comparison to predicate devices, and non-clinical performance data (mechanical testing, biocompatibility, sterilization validation, MRI compatibility). It explicitly states: "No clinical data were included in this submission."
Therefore, I cannot extract acceptance criteria or information about a study that proves the device meets those criteria in the context of an AI/ML device, as the provided text doesn't describe such a device or study.
If the request was based on a misunderstanding of the document's content, please clarify. If you're looking for general information on what would be included in such a study for an AI/ML device, I can provide a theoretical outline.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)